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In a randomised, double-blind study the efficacy and toxicity of oral fluconazole 50 mg daily and ketoconazole 200 mg daily were compared for the treatment of oropharyngeal candidiasis in patients with acquired immunodeficiency syndrome (AIDS) and AIDS-related complex (ARC). 20 episodes (18 patients) were treated with fluconazole and 20 episodes (19 patients) with ketoconazole. Pretreatment clinical features and laboratory test results were similar in both groups. 17 episodes (85%) in the fluconazole group and 16 (80%) in the ketoconazole group could be evaluated. There was clinical cure at the end of therapy in all fluconazole-treated and 12 of 16 (75%) ketoconazole-treated episodes. Cultures were negative at the end of therapy in 87% of the fluconazole group and 69% of the ketoconazole group. 1 patients stopped taking fluconazole because of severe nausea. 1 of 18 fluconazole-treated and 4 of 19 ketoconazole-treated patients had transient rises in alanine or aspartate aminotransferase. Fluconazole seemed more effective than ketoconazole in the treatment of oral thrush among AIDS and ARC patients.
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PMID:Comparison of fluconazole and ketoconazole for oropharyngeal candidiasis in AIDS. 256 63

A vaccine has been prepared with ribosomes of Candida albicans serotypes a and b plus, as adjuvant, membrane proteoglycan from a nonencapsulated Klebsiella pneumoniae. A preliminary phase II trial without placebo control was conducted in 22 women with a history of frequent recurrences of vulvovaginal candidiasis (VVC). Initially, all the patients were treated locally with an antimycotic cream. Beginning at the same time, vaccine was taken orally in capsules containing 0.55 microgram active components. It was administered intermittently over six months, groups of women taking doses of two, three, six or nine capsules. Tolerance was excellent except for mild nausea, probably due to the excipients, in two patients taking nine capsules. Twenty patients completed the study. Only seven of them had a documented recurrence of VVC during the 6 months on vaccine. No recurrence occurred in the eight women taking six or nine capsules per day. Before the study, these 20 patients had had an average of 3.59 attacks of VVC per 6 months. On vaccine, the average rate of recurrence was only 0.55 attacks per 6 months. A multicentre placebo-controlled study of the efficacy of this vaccine is in progress to validate these encouraging preliminary results.
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PMID:Phase II study of D.651, an oral vaccine designed to prevent recurrences of vulvovaginal candidiasis. 268 57

An open study designed to compare the effectiveness and safety of clotrimazole troches with nystatin oral suspension in the prevention of oropharyngeal candidiasis was conducted. This study was performed as the troche form of clotrimazole was easier to administer and less costly than nystatin oral suspension. Sixty assessable patients were randomized to receive either clotrimazole troches (n = 32) or nystatin oral suspension (n = 28) for a 60-day period after receiving a renal allograft. The two groups were comparable in age, sex, type of transplant, and amount of immunosuppression. Both regimens were 100% effective in preventing the development of thrush in the patients studied. Adverse effects were infrequently seen in either group (one case of mild nausea in the clotrimazole group and three cases in the nystatin group). One patient chose to withdraw from the clotrimazole group, and eight patients withdrew from the nystatin group before completing 60 days of therapy (P = .002). Reasons given for withdrawal were the unpleasant taste of the drugs, or an inability to comply with the protocol. The cost of clotrimazole troches in the prophylactic doses given in this study was approximately one tenth that of nystatin oral suspension. Clotrimazole troches are effective, less expensive, and easier to self-administer than nystatin oral suspension.
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PMID:A comparative trial of clotrimazole troches and oral nystatin suspension in recipients of renal transplants. Use in prophylaxis of oropharyngeal candidiasis. 331 58

The records of 47 patients with a perinephric abscess diagnosed from 1975 to 1986 at 8 San Francisco Bay Area hospitals were reviewed. The mean age was 51 years. Fifty-five percent were females and 45%, males. The left kidney was affected in 47% of cases, the right kidney in 40%, both in 4%, and a transplanted pelvic kidney in 9%. Fever (55%), chills or diaphoresis (47%), flank pain (40%), abdominal pain (40%), and nausea or vomiting (32%) were the most common presenting symptoms. About half the patients had symptoms for 1 week or less and 12% had no symptoms. Fever was documented before diagnosis in 88% of patients. Abdominal mass (13%) or tenderness (49%), and flank mass (9%) or tenderness (42%) were seen less frequently, and 11% of patients did not have fever, flank, or abdominal findings. The most frequent underlying conditions included previous urologic surgery (45%), previous urinary tract infection (38%), diabetes mellitus (36%), and urinary tract stones (36%). Cultures of perinephric abscesses yielded gram-negative aerobes in 52% of patients, primarily Escherichia coli. Staphylococcus aureus was isolated in 26% of patients and anaerobes in 17%. A single pathogen was isolated in 71% and multiple isolates in 29%. Of interest and great potential therapeutic importance was culture of anaerobes, primarily Bacteroides spp. in 17%, Enterococcus spp. in 7%, and Candida albicans in 7%. Positive blood and urine cultures identified perinephric abscess organisms exactly in 58% and 37% of cases, respectively. Routine laboratory tests such as the white blood cell count and urinalysis were insensitive and non-specific for perinephric abscess. Leukocytosis and anemia at admission were seen in slightly more than half of the patients. For radiologic diagnosis, computerized tomographic scanning was most helpful. Ultrasound and intravenous pyelography were falsely negative in about one-third of cases. Mortality (13%) was low in this series when compared with earlier studies, and probably reflects modern medical care. Six patients (13%) died during hospitalization, 2 of whom had diagnosis of PNA established only at autopsy. Drainage of the perinephric abscess was carried out by open surgical drainage in 64% of patients, percutaneous drainage in 19%, and both in 13%. The initial procedure, whether open surgical drainage or percutaneous catheter drainage, was usually successful. Late complications included nephrocutaneous fistulas in 3 patients and disseminated candidiasis in 1 patient.
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PMID:Perinephric abscess. Modern diagnosis and treatment in 47 cases. 335 13

Uncomplicated urogenital and concomitant oropharyngeal gonorrhea in 424 male and female patients was treated in a randomized comparative study with 0.5 g of cefodizime (89 men and 54 women), 1 g of cefodizime (87 men and 52 women), or 1 g of cefotaxime (86 men and 56 women). The cure rates were 100% for men and women in the group given 0.5 g of cefodizime, 100% for men and women in the group given 1 g of cefodizime, and 99% for men and 100% for women in the group given 1 g of cefotaxime. The MICs of cefodizime and cefotaxime for the isolate of Neisseria gonorrhoeae ranged from 0.004 to 0.06 micrograms/ml. Chlamydia trachomatis was isolated before treatment in 15% and after treatment in 13% of all patients. Side effects, such as nausea, diarrhea, abdominal pain, genital candidiasis, and pain at the site of injection, developed in 4% of the patients given cefodizime. Side effects, such as vertigo, genital candidiasis, fatigability, and diarrhea, developed in 4% of the patients treated with cefotaxime. In both groups of patients, the side effects were mild and transient. Cefodizime and cefotaxime are safe and effective agents in the treatment of uncomplicated urogenital gonorrhea.
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PMID:Randomized comparative study of 0.5 and 1 g of cefodizime (HR 221) versus 1 g of cefotaxime for acute uncomplicated urogenital gonorrhea. 337 56

Ofloxacin, a new fluoroquinolone, was given to fifty patients (29 females and 21 males) aged 25 to 86 years with urinary tract infection or prostatitis. Urinary tract infections usually chronic and associated with urologic anomalies, included 17 cases of cystitis and 19 cases of pyelonephritis. 14 patients had prostatitis. Pathogens recovered from the urine were 26 E. coli, 2 Citrobacter, 4 Proteus mirabilis, 2 Klebsiella, 2 Enterobacter, 3 Serratia, 3 Staphylococcus aureus and 11 Pseudomonas. Minimal inhibitory concentrations of ofloxacin ranged from 0.03 to 0.12 microgram/ml (mean MIC: 0.6 microgram/ml) for 27 nalidixic acid-sensitive strains, and from 0.25 to 4 micrograms/ml (mean MIC: 1 microgram/ml) for 26 nalidixic acid-resistant strains. Ofloxacin was given as single drug therapy in all patients, in a daily dosage of 200 mg b.i.d. in 46 patients and 400 mg b.i.d. in 4 patients, for 7 to 97 days (average 40 days). Follow-up after discontinuation of treatment was 3 to 12 months. Therapeutic results were as follows: 17 cures for the 17 cystitis patients, 17 cures and 2 failures by relapse for the 19 cases of pyelonephritis, and 11 cures, 1 failure by persistence of bacteriuria and failure by relapse for the 14 cases of prostatitis. Digestive disorders, i.e. nausea, abdominal pain, constipation, occurred in 6 patients and required withdrawal of the drug in 1; candidiasis of the tongue was recorded in one patient and digestive complaints with neuropsychic disorders in another. Two patients had short-lived, moderate leukopenia with granulopenia and one had transient worsening of preexisting renal failure. Hepatic tolerance was good.
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PMID:[Ofloxacin (RU 43280): clinical evaluation in urinary and prostatic infections]. 353 29

Laboratory and clinical study was carried out on miconazole (MCZ), a new synthetic imidazole. The antifungal activity of MCZ was studied and expressed as MICs for clinical isolates. The drug proved to have the highest activity against Cryptococcus neoformans, with MICs of no more than 0.16 micrograms/ml for all isolates of this species. MICs of Torulopsis glabrata were 0.08-5 micrograms/ml for all isolates and those of Candida albicans and Candida tropicalis were 5-20 micrograms/ml for more than 90% of the isolates. Most of other strains were less than 10 micrograms/ml. When 3 healthy adult men were administered each with 200 mg of MCZ by intravenous drip infusion for 1.25 hours, the mean serum MCZ concentration was 1.39 micrograms/ml at the end of the infusion, then decreased rapidly to 0.49 microgram/ml in following 30 minutes, and then decreased gradually to 0.17 microgram/ml 6 hours later. The mean cumulative urinary excretion rate of the drug was as low as 3.0% at this stage. A total of 25 patients with ages of 30-78 years, comprising 17 men and 8 women, were treated with 200-1,800 mg of MCZ daily for 3-93 days. The clinical effectiveness was ascertained in 19 cases among the patients; 9 cases with candidiasis, 3 with cryptococcosis and 7 with aspergillosis. Clinical responses were excellent in 2, good in 9 and poor in 8 cases, and its efficacy rates was 58%. The efficacy rate of the combination therapy with other antifungal agents was 60% in comparison with 57% of MCZ alone. Adverse reactions to the drug such as nausea, vomiting and anorexia were observed in 3 cases (12%). Abnormal changes in laboratory parameters were also observed: 3 patients with elevations of GOT and GPT, and another with eosinophilia.
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PMID:[Laboratory and clinical study of intravenous miconazole]. 359 80

Twenty six children with candidiasis, aged between 5 months and 14 years, were treated with different formulations and regimens of ketoconazole. Fifteen children had alimentary tract candidiasis, two had oesophagitis, one had urinary tract candidiasis, two vaginitis, two septicaemia, one endo-ophthalmitis, and three had chronic pulmonary illness with persistence of Candida albicans in sputum. Daily drug doses ranged from 3 to 13 mg/kg and duration of treatment from seven days to 18 months. Pharmacokinetic studies in 22 of the children are reported. A total of 3 mg/kg/day given in three divided doses did not yield sufficiently high concentrations, which were achieved with a daily dose of 8 to 10 mg/kg. The effectiveness of treatment was proved by negative mycological tests (cultures or specific antibodies, or both) in 88%, by cure in 73%, and improvement in 11%. In three patients evaluation was not possible due to an insufficiently proved diagnosis. Nausea and pyrosis in four patients were the only side effects noted and no laboratory abnormalities were found. To achieve therapeutic concentrations of ketoconazole in children we suggest a daily dosage of 7 to 10 mg/kg in two or three divided doses.
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PMID:Pharmacokinetics of ketoconazole and treatment evaluation in candidal infections. 609 71

Ketoconazole, a new oral antifungal agent, was evaluated in the treatment of four patients with severe chronic mucocutaneous candidiasis refractory to standard antifungal therapy. Three had Candida esophagitis, and too had previously received intravenous amphotericin B. Initial ketoconazole dosage was 100 mg daily for patients weighing less than 30 kg and 200 mg daily for patients over 30 kg. All four patients showed dramatic improvement on the initial dose; three had complete clearing of mucous membrane and skin lesions within three weeks. Of the three patients with Candida esophagitis, one had complete clearing of esophagitis within one month and two were markedly improved. One patient required 400 mg daily to obtain complete clearing of skin and mucous membrane lesions. Two patients were maintained free of overt disease on one dose three times weekly but two patients relapsed and have required daily ketoconazole therapy to keep them free of Candida. The only side effects were mild nausea (two patients) occasional emesis at higher doses (two patients), and transient hypocholesterolemia (one patient). No adverse hematologic, gastrointestinal, or renal effects were noted. Ketoconazole appears to be a valuable oral antifungal agent for some patients with CMC.
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PMID:Successful treatment of chronic mucocutaneous candidiasis with ketoconazole. 625 9

Candida infection of the esophagus is a frequent occurrence in both symptomatic and asymptomatic patients. In the present study, 12 symptomatic consecutive patients with Candida esophagitis. were successfully treated with oral Ketoconazole in a single dose of 200 mg daily. Response to treatment occurred in 8 days or less, with complete resolution of symptoms and endoscopic clearing of lesions. We found Ketoconazole to be well tolerated except for one patient who developed nausea, vomiting, and facial flushing while on the drug, which seemed to have been precipitated by alcohol intake. No changes in liver function tests were noted. Ketoconazole in this study was universally effective. In addition, its ease of administration, cost effectiveness, and low toxicity make it, in our opinion, the initial therapy of choice for C. esophagitis.
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PMID:Ketoconazole treatment of Candida esophagitis--a prospective study of 12 cases. 630 14


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